Human InfluenzaPhase 4NCT01511744

Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine

A Phase 4 study testing Inactivated influenza split vaccine in people with Human Influenza, run by Hualan Biological Engineering, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Human Influenza
What is being tested?: Inactivated influenza split vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,000 participants
Where: 1 siteChina
Study dates: Nov 2011to Mar 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
Be able to abide by the requirement of clinical trial protocol to participate in follow up;
Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
Be able to comply with the requirement of clinical trial protocol;
Have no history of vaccination and vaccination with other product in latest 1 week;
Axillary temperature ≤37℃.

Who cannot join

Any history of severe illness, such as tumor, autoimmune disease, etc.;
Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
History of neurological symptom or physical signs;
Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
Bleeding physique or prolonged bleeding;
History of influenza infection or vaccination at least once within the past 6 months;

Show all 14Show fewer

History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
Fever (axillary temperature≥38℃) within the past 3 days;
Participating in another clinical trial;
History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
Any condition that, in the judgment of investigator, may affect trial assessment.

Trial locations and contacts

1 site in 1 country.

China1 site

Henan Province Center for Disease Preventionand Control
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)

Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immunity of age 3 and older population. Phase III clinical study was conducted in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.

In order to monitor and evaluate the safety and protective effect against influenza administered on age 3 and older population, therefore we conduct the phase IV clinical trial of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).

Read the detailed description

Select three sites to conduct this study in Henan, china. In the principle of informed consent and voluntary participation, adopt randomized and control design and include 6000 healthy subjects, among them, trial group 3000 persons, blank control group 3000 persons respectively and randomized dividing into 4 age groups.

The evaluation of safety: For all the vaccinated subjects, monitor general reaction and post-vaccination AEFI by mean of active soliciting and passive report. The evaluation of safety data mainly includes summary of clinical reaction endpoint, local and systemic adverse events of all subjects during the observation period and incidence rate of relevant ADR/AE.

The evaluation of immunogenicity: Respectively and randomly sample 600 persons from vaccination group and blank control group. Collect venous blood on the first day or 28 day of vaccination. Adopt international universal HI testing method(SRID) to carry out serology test.

The criteria for HI antibody test result:

Take 1:10 serum as the lowest dilutability. For subjects whose HI antibody <1:10 before immunization, calculate as 1:5 and their post-vaccination HI antibody titer≥1:40 will be as the seroconversion. For subjects HI antibody ≥1:10 before the vaccination, take post-vaccination HI antibody titer increases 4 times as seroconversion;
Take HI antibody titer≥1:40 as threshold of positive protection;
Take statistics of subject number whose serum HI antibody titer reach protective level (HI antibody titer≥1:40). Calculate protection rate of vaccine and 95% CI;
GMT titer and 95% CI. Evaluation of immune protective effect: Monitor Influenza Like Illness(ILI) to all subjects in monitoring place and conduct epidemiological survey to ILI. Collect nasopharyngeal swab and blood specimen during acute and recovery period for the laboratory test.

ILI refers to fever (body temperature≥38℃) with cough or pharyngalgia. Test influenza virus nucleic acid in nasopharyngeal swab. Isolate serum of blood specimen and carry out the test of serum antibody.

Evaluation indicator:

Statistics of ILI incidence rate in immune population
Statistics of incidence rate in monitoring place

Conditions: Human Influenza
Being tested: Inactivated influenza split vaccine
Keywords: Respiratory Tract Infections; Orthomyxoviridae Infections
Medical subject headings: Influenza, Human, Respiratory Tract Infections, Orthomyxoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inactivated influenza split vaccineBiological
Also called Hualan Bio
3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime

Study groups in NCT01511744
Study group	Role	What they receive
Inactivated influenza split vaccine	Experimental	Biological: Experimental: influenza split vaccine of 15 μg HA, one dose regime Receives: Biological: Inactivated influenza split vaccine
Blank control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety study
Include ADR, adverse event, and severe adverse event.
Measured: 28days

Secondary outcomes (1)

Observation of immune protective effect
Observe immunogenicity and immune protective effect by means of active and passive monitoring. Period is one year.
Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Mar 2012

First posted19 Jan 2012 (estimated)
Study startNov 2011
Primary completionNov 2011
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 6,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01511744
Sponsor's protocol ID: Hualanbio-influenza IV-001
Other IDs: Hualanbio-phase IV-001
Status last verified: Mar 2012
First submitted: 18 Jan 2012
Last updated: 14 Aug 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)
ClinicalTrials.gov ID: NCT01511744
Acronym / sponsor ID: Hualanbio-influenza IV-001
Conditions: Human Influenza
Keywords: Respiratory Tract Infections; Orthomyxoviridae Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,000 participants (actual)
Lead sponsor: Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Nov 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 19 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The criteria for HI antibody test result:

Take 1:10 serum as the lowest dilutability. For subjects whose HI antibody <1:10 before immunization, calculate as 1:5 and their post-vaccination HI antibody titer≥1:40 will be as the seroconversion. For subjects HI antibody ≥1:10 before the vaccination, take post-vaccination HI antibody titer increases 4 times as seroconversion;
Take HI antibody titer≥1:40 as threshold of positive protection;
Take statistics of subject number whose serum HI antibody titer reach protective level (HI antibody titer≥1:40). Calculate protection rate of vaccine and 95% CI;
GMT titer and 95% CI. Evaluation of immune protective effect: Monitor Influenza Like Illness(ILI) to all subjects in monitoring place and conduct epidemiological survey to ILI. Collect nasopharyngeal swab and blood specimen during acute and recovery period for the laboratory test.

Evaluation indicator:

Statistics of ILI incidence rate in immune population
Statistics of incidence rate in monitoring place

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Inactivated influenza split vaccine	Experimental	Biological: Inactivated influenza split vaccineBiological: Experimental: influenza split vaccine of 15 μg HA, one dose regime
Blank control	No intervention	–

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
Be able to abide by the requirement of clinical trial protocol to participate in follow up;
Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
Be able to comply with the requirement of clinical trial protocol;

Key exclusion criteria (14 listed)

Any history of severe illness, such as tumor, autoimmune disease, etc.;
Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
History of neurological symptom or physical signs;
Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
Bleeding physique or prolonged bleeding;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inactivated influenza split vaccineAlso: Hualan Bio3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime	Biological	Inactivated influenza split vaccine

Primary outcome

Safety study
Time frame: 28days
Include ADR, adverse event, and severe adverse event.

1 secondary outcome

Observation of immune protective effect
Time frame: 1year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xu Bianli, Master principal investigator

Henan Province Center for Disease Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated influenza split vaccine in people with Human Influenza, run by Hualan Biological Engineering, Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety study (time frame: 28days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01511744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.